Z-1542-2009

TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model...

Name: Z-1542-2009 TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2009-01-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-01-28 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray... on 2009-01-28. The reason FDA records is "A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1542-2009
Status: Terminated
Initiated: 2009-01-28
Posted: 2009-07-13
Terminated: 2012-09-19
Recalling firm: Philips North America LLC
Product: TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.
Quantity in commerce: 356 units
Distribution: Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela.
Product codes and lots: Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW.

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)